Low-Profile Vascular Closure Systems and Methods of Using Same

ABSTRACT

A closure device for an arteriotomy includes an elongate tube having a distal opening. The elongate tube has least two opposing longitudinal slots and a pair of opposing corners defined where each slot meets the distal opening. A staple is disposed within the tube, the staple having at least two opposing legs aligned with the at least two slots. Each slot is pinched together adjacent the distal opening such that the opposing corners of each slot converge to cover the tip of the respective staple leg to guard the staple tips against contact with the tissue track. The corners of each slot are separable to permit the respective staple leg to pass there between.

FIELD OF THE INVENTION

The present disclosure relates to system and method for closing anopening in a vessel wall after a medical procedure, and in particular,to a system and method for closing a puncture arteriotomy after anintra-luminal procedure such as catheterization.

BACKGROUND OF THE INVENTION

Catheters/catheterization procedures for diagnosis or treatment ofcardiovascular and/or peripheral vascular diseases are well known, andtypically involve the Seldinger technique to make insertions throughlayers of tissue and through a wall of the femoral artery. After adiagnostic or interventional catheterization, the arteriotomy punctureformed by the catheter or introducer sheath must be closed. The punctureopening in the artery typically ranges from 5 French (0.0655 inch, 1.67mm) such as for a diagnostic angiography procedure to as large as 30French (0.393 inch, 10.00 mm) for an interventional procedure such asimplanting an inferior vena cava (IVC) filter. Traditionally, intensepressure has been applied to the puncture site for at least 30-45minutes after removal of the catheter. Patients who have had a femoralartery puncture are then required to remain at bed rest, essentiallymotionless and often with a heavy sandbag placed on their upper legs,for several hours to ensure that the bleeding has stopped. Otherapproaches include the use of a thrombotic or collagen plug or slurry,and/or other suturing methodologies for sealing the puncture. Also knownare systems and methods for blind delivery, viz., without directvisualization, of a staple or clip to gather and hold together sides ofthe arteriotomy. However, these closure systems typically deliver, orperform the closure modality via a sheath, which holds the tissue trackopen. Therefore, there is a need for a low-profile closure system.

BRIEF SUMMARY OF THE INVENTION

A method for closing an arteriotomy in a wall of a vessel of a bodyafter an intra-luminal procedure is disclosed. The terms “distal” and“proximal” are used in the specification with respect to a position ordirection relative to the treating clinician. “Distal” or “distally” area position distant from or in a direction away from the clinician.“Proximal” and “proximally” are a position near or in a direction towardthe clinician. The method may be practiced without a sheath in place inthe tissue track. A guidewire from the intra-luminal procedure remainsin the vessel or is replaced with another guidewire. A proceduralsheath, if used, is removed from the patient. A dilator and a guidingsystem are advanced together along the guidewire into the body tissue,through the arteriotomy and are into the vessel lumen. The guidingsystem includes at least two stabilization wire guides, eachstabilization wire guide having a deployable retention foot disposed ata distal portion thereof. The guiding system is deployed within thevessel lumen such that the retention feet can be pulled back against aninner surface of the vessel wall. The guidewire and dilator arewithdrawn from the lumen and the body tissue, leaving only the guidingsystem in place. A closure system is advanced along the guiding systemto a position proximal to the arteriotomy. The closure system includes acenter tube housing a stapler, the center tube having at least two sidetubes for riding along the stabilization wire guides. The stapler isthen activated to close the arteriotomy and the guiding system andclosure system are withdrawn from the lumen and the body.

An embodiment of the stapler includes an elongate hollow shaft having atits distal end a pair of opposing actuation tips that define a staplechamber there between. An anvil extends into the staple chamber from oneof the actuation lips to retain and deform a staple. An elongate driveris slidably disposed in the hollow shaft. A staple includes a pair ofopposing legs proximally coupled by a bend and having an expansion rampextending from each leg toward the other leg. The staple may be openedand/or closed by plastic or elastic deformation. When the closure systemis disposed adjacent to the arteriotomy, an operator mechanism moves thedriver longitudinally relative to stapler shaft such that the driveradvances the staple between the actuation tips. The staple expansionramps ride and spread apart along the anvil, thereby opening the staple.As the operator continues to push the driver longitudinally, the stapleexpansion ramps clear the anvil, permitting the staple to close. In anembodiment of the stapler, the driver closes the staple by deforming thestaple bend against the anvil. In another embodiment, of the stapler,the staple is elastically self-closing. A staple release mechanism isactuated to spread the actuation tips apart, creating a gap throughwhich the staple is released from the anvil.

In an embodiment of the closure system, a distal portion of the centertube is pinched such that it separates the staple tips from the tissuetrack during delivery to the arteriotomy site. When the staple isdeployed, the staple spreads the pinched portion apart.

In another embodiment of the closure system, a frangible cap is disposedover the distal opening of the center tube. The frangible cap separatesthe staple tips from the tissue track during delivery to the arteriotomysite. When the staple is deployed, the staple perforates or fracturesthe frangible cap. Optionally, a portion of the frangible cap tears awayfrom the center tube to form a pledget that is retained against thearteriotomy by the staple.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other features and advantages of the presentdisclosure will be apparent from the following description of thedisclosure as illustrated in the accompanying drawings. The accompanyingdrawings, which are incorporated herein and form a part of thespecification, further serve to explain the principles of the disclosureand to enable a person skilled in the pertinent art to make and use thedisclosure. The drawings are not to scale.

FIG. 1 is a cross-sectional view of body tissue including a vessel witha procedural device inserted in the vessel.

FIG. 2 is cross-sectional view of body tissue including a vessel with aguidewire inserted in the vessel.

FIG. 3 is cross-sectional view of body tissue including a vessel with aprocedural sheath being removed from the tissue.

FIG. 4 is a cross-sectional view of an embodiment of a dilator andretention system being inserted into body tissue.

FIG. 5 is a cross-sectional view of the dilator and retention system ofFIG. 4 being inserted into a vessel through an arteriotomy.

FIG. 6 is a cross-sectional view of the dilator and retention system ofFIG. 4 with stabilization wire guides released from the dilator.

FIG. 7 is a cross-sectional view of retention feet of the stabilizationwire guides of FIG. 6 deployed within a vessel and the guidewire beingremoved from the vessel and body tissue.

FIG. 8 is a cross-sectional view of the retention feet of FIG. 7deployed and the dilator being removed from the vessel and body tissue.

FIG. 9 is a cross-sectional view of an embodiment of a closure system asit enters the body tissue.

FIG. 10 is a cross-sectional view of the closure system of FIG. 9 as itreaches a location just outside of the vessel, adjacent the arteriotomy.

FIG. 11 is a perspective view of the closure system of FIG. 9 withexpansion tips extended beyond a distal opening of a center tube,

FIG. 12 is a perspective view of the closure system of FIG. 9 as astaple is being deployed.

FIG. 13 is a perspective view of the closure system of FIG. 9 with thestaple deployed to close the arteriotomy.

FIG. 14 is a perspective view of the closure system of FIG. 9 with thestaple deployed and the center tube and stabilization wire guides beingremoved from the body tissue.

FIG. 15 is a perspective cut-away view of an embodiment of a stapler ofthe present disclosure.

FIG. 16 is a perspective cut-away view of the stapler of FIG. 15 withthe staple being deployed.

FIG. 17 is a perspective cut-away view of the stapler of FIG. 15 withthe staple closed after deployment.

FIG. 18 is a plan view of an embodiment of a staple of the presentdisclosure.

FIG. 19 is a perspective view of the staple of FIG. 18.

FIG. 20 is a cut-away perspective view of another embodiment of astapler of the present disclosure.

FIG. 21 is a cut-away side view of the stapler of FIG. 20 with thestaple being deployed.

FIG. 22 is a cut-away side view of the stapler of FIG. 20 with thestaple closed, but not released.

FIG. 23 is a perspective view of an embodiment of an expansion tip ofthe stapler of FIG. 20.

FIG. 24 is an end view of an embodiment of a pair of expansion tips ofthe stapler of FIG. 20.

FIG. 25 is a perspective view of a center tube with a pinched distalportion of the present disclosure.

FIG. 26 is a perspective view of the center tube of FIG. 25 duringdeployment of a stapler.

FIG. 27 is a perspective view of a center tube with a frangible cap ofthe present disclosure.

FIG. 28 is a perspective view of the center tube of FIG. 27 duringdeployment of a stapler.

FIG. 29 is a perspective view of another embodiment of the center tubeof FIG. 27 with a pledget formed from a frangible cap during deploymentof a staple.

FIG. 30 is a perspective view of the closure system of FIG. 44 with thestaple and pledget deployed and the center tube and stabilization wireguides being removed from the body tissue.

FIG. 31 is a longitudinal cross-sectional view of a top view of anembodiment of a release mechanism for releasing a staple from a staplerof the present disclosure.

FIG. 32 is a longitudinal cross-sectional view of a top view of theembodiment of FIG. 31 with the actuation tips spread apart.

FIG. 33 is a longitudinal cross-sectional view of a top view of anotherembodiment of a release mechanism for releasing a staple from a staplerof the present disclosure.

FIG. 34 is a longitudinal cross-sectional view of a top view of theembodiment of FIG. 29 with the actuation tips spread apart.

FIG. 35 is a cut-away side view of a stapler with another embodiment ofa release mechanism for releasing a staple from a stapler of the presentdisclosure.

FIG. 36 is a cut-away side view of the embodiment of FIG. 35 with thestaple deployed, but not released from the stapler.

FIG. 37 is a cut-away perspective view of a portion of the embodiment ofFIG. 35.

FIG. 38 is longitudinal cross-sectional view of a top view of theembodiment of FIG. 35 with the actuation tips spread apart.

FIG. 39 is a perspective view of an actuation tip of another stapler inaccordance with the disclosure.

FIG. 40 is a top view of a stapler incorporating the actuation tip ofFIG. 39 with the staple deployed, but not released from the staplechamber.

FIG. 41 is a top view of the stapler of FIG. 40, after the staple hasbeen pushed forward to spread apart the actuation tips.

FIG. 42 is a cut-away side view of a stapler with another embodiment ofa release mechanism for releasing a staple from a stapler of the presentdisclosure.

FIG. 43 is a perspective view of an expansion tip of the stapler of FIG.42.

FIG. 44 is a cut-away side view of the stapler of FIG. 42 with thestaple closed, but not released from the stapler.

FIG. 45 is a transverse cross-section view along line 45-45 of FIG. 44with the actuation tip that was cut away from FIGS. 42 and 44.

FIG. 46 is an alternative embodiment of the stapler of FIGS. 42-44,shown in a transverse cross-section view along line 46-46 of FIG. 44with the actuation tip that was cut away from FIGS. 42 and 44.

FIG. 47 is an outline of a method of using a vascular closure system inaccordance with the disclosure.

DETAILED DESCRIPTION OF THE INVENTION

Low Profile Guiding System

Specific embodiments of the present disclosure are now described withreference to the figures, where like reference numbers indicateidentical or functionally similar elements. The present disclosure isdirected to a device and method for closing an arteriotomy after aprocedure in which a vessel was punctured to gain access to the vessellumen. FIGS. 1-10 show cross-sectional views of body tissue 100 with avessel 102 disposed therein. FIG. 1 shows a procedural device 108, suchas a balloon catheter, disposed partially within a lumen 104 of vessel102. The distal end of procedural device 108 is shown riding along aguidewire 110. Procedural device 108 passes through a procedural sheath106, which maintains access to lumen 104 through a tissue track 101 intissue 100 and arteriotomy 132 in the wall of vessel 102.

As the intra-luminal procedure, such as balloon angioplasty, iscompleted, procedural device 108 is removed from vessel 102 and tissuetrack 101 via procedural sheath 106, as shown in FIG. 2. Guidewire 110remains in place partially disposed within lumen 104 of vessel 102. Asshown in FIG. 3, procedural sheath 106 is removed from lumen 104,arteriotomy 132, and tissue track 101, leaving guidewire 110 in place.Although tissue track 101 and arteriotomy 132 are shown in FIG. 3 asbeing maintained in an open state, in practice, tissue track 101 andarteriotomy 132 will tend to at least partially close around guidewire110 when procedural sheath 106 is removed.

A vascular closure system of the disclosure is used to close arteriotomy132, as follows. As shown in FIG. 4, a dilator 112 is guided along guidewire 110 into tissue track 101. Provided with dilator 112 is a pair ofstabilization wire guides 114. Stabilization wire guides 114 ride alongan outside surface of dilator 112. Distal portions of stabilization wireguides 114 are inserted into respective openings 116 in dilator 112 sothat stabilization wire guides 114 advance with dilator 112 into tissuetrack 101. As shown in FIG. 5, dilator 112 and stabilisation wire guides114 are advanced farther along guidewire 110 into lumen 154. As dilator112 is advanced into tissue track 101 and arteriotomy 132, dilator 112opens tissue track 101 and arteriotomy 132.

As shown in FIG. 6, dilator 112 and stabilization wire guides 114 areadvanced far enough into lumen 104 of vessel 102 to ensure thatretention feet 118 are intraluminal prior to their deployment. Numerousmethods are known to those of skill in the art to measure or accuratelyindicate the intraluminal position of portions of a vascular closuredevice. In one known device, intraluminal position of the device may beindicated by blood entering the device through an inlet port positionedwithin the vessel lumen, the blood flowing through a passageway in thedevice, and the blood finally emitting from the device as a visible“flashback” out of art exit port external to the patient. In analternative known type of position indicator, the device may have anenlarged physical stop for abutting against the external wall of theblood vessel to provide a tactile indication of the position of thedevice with respect to the vessel wall.

Dilator 112 is advanced farther into lumen 104 of vessel 102 whilestabilization wire guides 114 are restricted from movement. Thisrelative movement between dilator 112 and stabilization wire guides 114causes the distal portions of stabilization wire guides 114 to beexposed or released from openings 116 in dilator 112. Stabilization wireguides 114 are manipulated or deployed to form retention feet 115 in thedistal portions thereof. Retention feet 118 may be formed in variousways as would be known to those of ordinary skill in the art, forexample, the ways described in FIGS. 49-57 of U.S. Pat. No. 6,767,356 toKanner et al., the entire disclosure of which is incorporated herein byreference. Retention feet 118 are pulled back against an inner wall 120of vessel 102, thus providing temporary anchoring for stabilization wireguides 114, and also providing an indication of the location, or depthof inner wail 120 relative to other components of the vascular closuresystem. For convenience of illustration, FIGS. 5-10 show a pair ofstabilization wire guides 114 aligned along the axis of vessel 102. Inactual use however, such a pair of stabilization wire guides 114 willtypically be aligned transverse to the axis of vessel 102 and positionedat the ends of the slit that naturally forms generally perpendicular tothe length of the vessel when arteriotomy 132 is formed in the wall ofvessel 102, as described in the above-mentioned Kanner '356 patent. Suchtransverse alignment of stabilization wire guides 114 within arteriotomy132 is especially typical when stabilization wire guides 114 are spreadapart by closure system 122 as described below.

Referring to FIGS. 7 and 8, guidewire 110 and dilator 112 are removedfrom lumen 104, arteriotomy 132 and tissue track 101, leaving onlystabilization wire guides 114 extending through tissue track 101 andarteriotomy 132 into lumen 104. Stabilization wire guides 114 provideguidance for insertion of a closure system. Referring to FIGS. 9 and 10,a closure system 122 is slidably mounted onto stabilization wire guides114 so that a distal portion of closure system 122 can ride alongstabilization wire guides 114 to a location within tissue track 101spaced proximally from vessel 102. Closure system 122 includes anelongate stapler 128 carried slidably within a center tube 124. Two ormore relatively short side tubes 126 are coupled parallel to the distalportion of center tube 124 on opposing sides thereof. In an embodiment,center tube 124 may be 30 cm long and side tubes may be 2 cm long.Center tube 124 and side tubes 126 will separate stabilization wireguides 114 when closure system 122 is advanced there along. Separatingstabilization wire guides 114 applies tension along the long axis ofslit-shaped arteriotomy 132 such that tissue along both sides ofarteriotomy 132 tends to come together for engagement by a closuresystem, as described in the above-mentioned Kanner '356 patent.

FIG. 11 shows a side view of an embodiment of the present disclosure.Vessel 102 is shown in longitudinal cross-section and tissue 100 hasbeen excluded for convenience of illustration. With retention feet 118deployed within lumen 104 of vessel 102, closure system 122 is advancedtoward arteriotomy 132 until the distal end of closure system 122 isstopped extraluminally at a preset distance from retention feet 118. Thedistance between the distal end of closure system 122 and retention feet118 may be preset in a mechanism (not shown) coupled to the proximalends of stabilization wire guides 114 and center tube 124. Afterconfirming the apposition of retention feet 118 against inner wall 120of vessel 102, as shown in FIG. 11, stapler 128 may be advanced distallywithin center tube 124 to expose a pair of actuation tips 129 and astaple 130 held there between.

As shown in FIG. 12, two staple tips 139 of staple 130 are expandedlaterally and are extended distally from between actuation tips 129 topierce vessel tissue on either side of arteriotomy 132. Note that,whereas side tubes 126 and stabilization wire guides 114 are describedas being disposed on “sides” of stapler 128, then “lateral” expansion ofstaple tips 139 means the tips expand toward the top and bottom ofstapler 128. It will be understood by one of skill in the art that top,bottom and side are terms used only to assist the reader inunderstanding the relative positions of the components of thedisclosure. Staple tips 139 are then closed to gather or pucker theengaged tissue, thus closing arteriotomy 132. Staple 130 is releasedfrom stapler 128 to remain embedded in vessel 102. Described furtherbelow are several embodiments of the disclosure that are suitable forreleasing a staple from a stapler. Stabilization wire guides 114 andclosure system 122, except for staple 130, are then removed from thebody, as shown in FIG. 14. Actuation tips 129 and staple 130 may beconventional as would be known to one of ordinary skill in the art, suchas the actuating tip portion of a stapler and the staple shown in FIGS.67-71 of the above-mentioned Kanner '356 patent.

First Stapler Embodiment

FIGS. 15-19 show an embodiment of a stapler 228 of the presentdisclosure. In particular, FIG. 15 is a cut-away perspective view ofstapler 228. FIG. 47 outlines a method 1000 of using staplers inaccordance with the disclosure, including stapler 228. Stapler 228includes an elongate hollow shaft 227. At the distal end of hollow shaft227 is a pair of flat-sided, opposing actuation tips 229 (only one tip229 a is shown in FIGS. 15-17). The flat sides of actuation tips 229face each other and are spaced apart to provide a passageway forslidably receiving a flat distal portion of an elongate driver 240, andto provide an open-sided staple chamber for holding at least a proximalportion of a staple 230. The open sides of the staple chamber areoriented toward the top and bottom of stapler 228. For example, seestaple chamber 345 in FIG. 24. The distal end of driver 240 has a pairof tip edges 242 arranged to form an axially symmetrical pointed tip forabutment against a proximal end of staple 230. An anvil 250 fordeforming or deflecting staple 230 is fixed within the staple chamber.Single anvil 250 may be dimensioned to substantially span the staplechamber, as illustrated in FIG. 46, and may be integrally formed with orattached to actuation tip 229 a, without being affixed to oppositeactuation tip 229 b. Alternatively, anvil 250 may be formed by twomating anvil halves, each anvil half being integral with or attached toactuation tip 229 a or 229 b, respectively. Driver 240 extendsproximally within hollow shaft 227 to a handle (not shown) wherein amechanism may be manually operated to move driver 240 within hollowshaft 227, as will be understood by one of ordinary skill in the art ofmedical stapling devices. In an embodiment, driver 240 and hollow shaft227 may each be about 30 cm in length. Staple 230 includes two legsrespectively having proximally-located expansion bends 236 a and 236 bconnected by a closure bend 237. The two legs of staple 230 respectivelyhave staple expansion ramps 234 a and 234 b, optional staple tissuestops 238 a and 238 b, and staple tips 239 a and 239 b. See step 1010 inFIG. 47.

In practice, the distal portion of stapler 228 is positioned at a presetdistance from an arteriotomy, as shown with respect to stapler 128 inFIG. 11. See also step 1020 in FIG. 47. Driver tip edges 242 a and 242 babut expansion bends 236 a and 236 b at the proximal end of staple 230.Staple tips 239 a and 239 b extend from the distal end of hollow shaft227, even prior to the initiation of deployment of staple 230 fromstapler 228. Driver 240 is advanced distally within hollow shaft 227such that driver tip edges 242 a and 242 b push staple 230 distally inthe staple chamber formed between actuation tips 229 such that stapleexpansion ramps 234 a and 234 b ride along, and are forced apart byanvil 250. The separation of expansion ramps 234 a and 234 b causes thelegs of staple 230 to separate and extend laterally through the opensides, i.e. top and bottom of the chamber along the distal portion ofhollow shaft 227. As the legs of staple 230 are spread apart, expansionbends 236 a and 236 b are forced open and staple tips 239 a and 239 bseparate from each other, as shown in FIG. 16. See also step 1030 inFIG. 47. The deformation of expansion bends 236 a and 236 b as they areopened may exceed the elastic limits of the staple material such that atleast some plastic deformation may occur. Simultaneously, or closelycoordinated with the spreading of the staple legs, staple 230 isadvanced distally such that staple lips 239 a and 239 b pierce vessel102 to engage vessel tissue on either side of arteriotomy 132. See step1040 in FIG. 47. Stabilization wire guides 114 aid in centering, orstabilizing closure system 122 over arteriotomy 132, as shown in FIGS.11 and 12. The expanded distance between tips 239 a and 239 b more than,spans arteriotomy 132, as shown with respect to staple 130 in FIG. 12.As described in the above-mentioned Kanner '356 patent, staple tissuestops 238 a and 238 b help prevent tips 239 a and 239 b respectivelyfrom fully penetrating the wall of vessel 102 and entering lumen 104.

As driver 240 continues to be moved distally in hollow shaft 227, stapleclosure bend 237 abuts anvil 250, and staple expansion ramps 234 a and234 b clear anvil 250, permitting at least some elastic recovery ofstaple expansion bends 236 a and 236 b. See step 1050 in FIG. 47. Drivertip edges 242 a and 242 b force closure bend 237 against anvil 250,thereby deforming closure bend 237 into a more open angle. Thedeformation of closure bend 237 may exceed the elastic limits of thestaple material such that at least some plastic deformation may occur.Opening closure bend 237 causes the legs of staple 230 to pivot inopposite directions around the apex of closure bend 237 such that stapletips 239 a and 239 b move toward each other, as shown in FIG. 17. Asstaple tips 239 c and 239 b are forced together, the vessel tissuebetween them is gathered or puckered, thereby closing arteriotomy 132.When staple 230 closes, staple tips 239 a and 239 b may approach, ortouch, or even cross over each other as shown in FIGS. 13, 14 and 17,depending upon the amount of tissue between the tips,

First Staple Release Mechanism

As staple tips 239 a and 239 b close toward each other, the proximalportion of staple 230 must be released from stapler 228. Otherwise, asshown in FIG. 17, the proximal portion of staple 230 would be trapped byanvil 250. There are several ways for staple 230 to be released fromstapler 228. FIGS. 31 and 32 are top sectional views of stapler 228,with staple 230 being omitted for clarity. Driver 240 may include adistal wedge 244, or distally-facing wedges 244 a and 244 b, disposedproximally from driver distal edge 242. Wedges 244 a and 244 b extendlaterally outward from side surfaces 246 a and 246 b of driver 240 inthe direction of actuation tips 229 a and 229 b, respectively. Further,actuation tips 229 a and 229 b include proximally-facing ramps 270 a and270 b, respectively, disposed proximally from anvils 250 a and 250 b. Asdescribed above, driver 240 is moved distally within hollow shaft 227such that closure bend 237 is opened to force staple tips 239 a and 238b together. In a simultaneous movement, wedges 244 a and 244 b pushagainst and slide along ramps 270 a and 270 b, respectively, therebycausing actuation tips 229 a and 229 b to spread apart, from each other,as shown in FIG. 32. With actuation tips 229 a and 229 b spread apartfrom each other, a gap 272 is formed between anvil 250 a of actuationtip 229 a and anvil 250 b of actuation tip 229 b, thereby releasingstaple 230 from the staple chamber of stapler 228. See step 1060 in FIG.47. Staple 230 is thus permitted to remain in place, closing thearteriotomy as stapler 228, including hollow shaft 227, actuation tips229 a and 229 b and driver 240, is removed from the body. With thisembodiment, it is important to have close dimensional tolerances betweenanvil 250 and ramps 270 a and 270 b, and between driver distal edge 242and wedges 244 a and 244 b to ensure coordination between stapledeployment and release.

Second Staple Release Mechanism

FIGS. 33 and 34 are top sectional views of another stapler 228′, withstaple 230 being omitted for clarity. In the embodiment shown in FIGS.33 and 34, driver 240′ includes proximally-facing wedges 244 a′ and 244b′ disposed proximally from driver distal edge 242′, and actuation tips229 a′ and 229 b′ include distally-facing ramps 270 a′ and 270 b′,respectively, disposed proximally from anvils 250 a and 250 b. FIG. 33shows stapler 228′ after staple 230 has been deployed, but not released.In order to release the staple from anvils 250 a′, 250 b′, driver 240′is moved proximally such that wedges 244 a′ and 244 b′ engage ramps 270a′ and 270 b′, respectively. Ramps 270 a′ and 270 b′ ride up wedges 244a′ and 244 b′, thereby forcing actuation tips 229 a′ and 229 b′ apartfrom each other and releasing the staple, as shown in FIG. 34. Thisembodiment is less sensitive to dimensional tolerances than theembodiment shown in FIGS. 31 and 32 because staple 230 is fully deployedbefore driver 240′ is moved proximally to release staple 230.

Third Staple Release Mechanism

In another embodiment of a stapler 228″ shown in FIGS. 35-38, releasemechanisms 280 a and 280 b are provided coupled to each side of driver240″. FIGS. 35 and 36 are side sectional views of stapler 228″. Releasemechanisms 280 a and 280 b each includes a base 282 a and 282 b, a pairof arms 284 a/b and 285 a/b, and hooks 286 a/b and 287 a/b extendinglaterally outward from arms 284 a/b, 285 a/b, respectively. Actuationtips 229 a″ and 229 b″ (only actuation tip 229 a″ is shown in FIGS.35-37) include notches 288 a/b and 289 a/b having ramps 290 a/b and 291a/b. FIG. 35 shows stapler 228″ with staple 230 in the pre-deploymentconfiguration as stapler 228″ is being delivered to the arteriotomysite. Arms 284 a/b and 285 a/b of release mechanisms 280 a/b areresiliently compressed toward each other by sidewalks 292 a/b and 293a/b of actuation tips 229 a″ and 229 b″. As driver 240″ is moveddistally within hollow shaft 227″ to push staple 230 against anvil 250a/b, hooks 286 a/b and 287 a/b arrive at notches 288 a/b and 289 a/b.Sidewalls 292 a/b and 293 a/b no longer compress arms 284 a/b and 285a/b as hooks 286 a/b and 287 a/b resiliently extend into notches 285 a/band 289 a/b, respectively, as shown in FIG. 36. After staple 230 hasbeen deployed to close the arteriotomy, driver 240″ is moved proximally,thereby also moving release mechanisms 280 a and 280 b proximally, asshown in FIG. 37. As release mechanisms 280 a and 280 b are movedproximally, hooks 286 a/b and 287 a/b ride up ramps 290 a/b and 291 a/b.This motion causes actuation tips 229 a″ and 229 b″ to spread apart,thereby providing a gap 272 between anvils 250 a and 250 b through whichstaple 230 may pass, as shown in the top sectional view of stapler 228″shown in FIG. 38. Note that, as described above, staplers 228, 228′ and228″ may include a single anvil 250 extending from one actuation tiptoward the other actuation tip instead of a pair of anvils 250 a and 250b. Similar to stapler 228′ above, stapler 228″ is less sensitive todimensional tolerances because staple 230 is fully deployed beforedriver 240″ is moved proximally to release staple 230.

Staple Materials

Staple 230 may comprise a biocompatible metal such as nitinol (TiNi),stainless steel, tantalum, or titanium. Magnesium or an alloy thereofmay also be used to make staple 230, and such materials also have thepotential advantage of being bioabsorbable. Staple 230 may also beformed from various filled or unfilled rigid or semi-rigid polymers suchas liquid crystal polymer (LCP), polyamide, polycarbonate,poly-etheretherketone (PEEK), polysulfone, polyvinylidene fluoride(PVDF), and may include bioabsorbable or biodegradable polymericmaterials such as polycaprolactone, poly(glycolide) (PGA),poly(L-lactide) (PLLA) and poly(D,L-lactide) (PLA). In an example of amethod of making a staple embodiment of the disclosure, staple 230 mayformed of a rigid thermoplastic in an injection mold. Staple 230 may beopened by elastic and/or plastic deformation of expansion bends 236 aand 236 b and may be closed by elastic and/or plastic deformation ofclosure bend 237. Combined elastic and plastic deformation refers to astaple that has had its shape changed to exceed the elastic region ofits material properties, so the staple will only tend to return part wayto its previous shape.

Second Stapler Embodiment

In another embodiment, FIGS. 20-24 show an embodiment of a stapler 328of the present disclosure. In particular, FIG. 20 is a cut-awayperspective view of stapler 328. Stapler 328 includes an elongate hollowshaft 327 having, at its distal end, a pair of flat opposing actuationtips 329 (only one tip 329 a is shown in FIGS. 20-23) spaced apart toprovide an open-sided chamber for holding a staple 330. An elongatedriver 340 is slidably disposed within hollow shaft 327 and has a flatdistal portion slidingly disposed within the chamber. The distal end ofdriver 340 may be shaped, e.g. concave, for abutment against a proximalbend of staple 330. Anvil 350 for retaining and deflecting staple 330may extend substantially across the staple chamber and may be integralwith or attached to actuation tip 329 a, without being affixed toopposite actuation tip 329 b. Alternatively, anvil 350 may be formed bytwo mating anvil halves 350 a and 350 b, each anvil half being integralwith or attached to actuation tip 329 a or 329 b, respectively, Only oneanvil 350 a is shown in FIGS. 20-23. Driver 340 extends proximallywithin the hollow shaft to a handle (not shown) wherein a mechanism maymove the driver 340 relative to the hollow shaft and actuation tips 329,as described above with respect to stapler 228.

Stapler 328 includes a staple 330 made according to a material and aprocess such that it lends to elastically return to a closed shape, aswill be described with respect to FIGS. 20-22. Staple 330 may be made ofnitinol or other suitable elastic or pseudoelastic shape memory alloy(SMA) that may be heat set in a relaxed or neutral configuration such asthe closed configuration shown in FIGS. 20 and 22. Staple 330 is carriedwithin stapler 328 and staple 330 may be heat set in a pre-formed orrelaxed configuration with staple tips 339 a and 339 b crossed over eachother, or barely touching each other, or spread slightly apart as shownin FIG. 20. Staple tips 339 a and 339 b extend from the distal end ofhollow shaft 327, even prior to the initiation of deployment of staple330 from stapler 328. Staple 330 includes two legs connected by aproximal bend. The legs respectively have staple expansion ramps 334 aand 334 b, optional staple tissue stops 338 a and 338 b, and staple tips339 a and 339 b.

When stapler 328 is in the proper position with respect to vessel 102,driver 340 is advanced distally within hollow shaft 327 such that thedriver distal end pushes staple 330 distally in the staple chamberbetween expansion tips 329, and staple expansion ramps 334 a/334 b ridealong, and are forced apart by anvil 350, as shown in FIG. 21. Theseparation of expansion ramps 334 a and 334 b causes the legs of staple330 to separate and extend laterally from the open sides of the staplechamber in the distal end of hollow shaft 327. In a simultaneous action,staple tips 339 a and 339 b are spread apart, the proximal staple bendis opened up, and staple 330 is advanced distally such that staple-tips339 a and 339 b pierce the vessel wail (not shown) to engage vesseltissue on either side of arteriotomy 132 (not shown). Referring to FIG.22, as driver 340 continues to push staple 330 distally, expansion ramps334 a and 334 b clear anvil 350, and the elastic or shape memoryproperty of the proximal bend of staple 330 causes staple tips 339 a and339 b to close toward each other. As staple tips 339 a and 339 b drawtogether, the vessel tissue between them is gathered or puckered,thereby closing the arteriotomy. When staple 330 closes, staple tips 339a and 339 b may again approach, or touch, or even cross over each other,depending upon the pre-formed staple configuration and the amount oftissue gathered between the tips.

The hollow shaft of stapler 328 and expansion tips 329 a and 329 b maybe made of metal or stiff plastic suitable for insertion into the humanbody, such as stainless steel, nitinol, high density polyethylene,polyamide, or polyethylene block amide copolymer. FIG. 23 shows aperspective view of actuation tip 329 a, including anvil 350 and siderails 360 a and 361 a, which terminate proximally of the distal ends ofexpansion tips 329 a and 329 b. Side rails 360 a and 361 a abut siderails 360 b and 361 b of expansion tip 329 b, as shown in FIG. 24, thusforming passageway 362 there between for slidably receiving the fiatdistal portion of driver 340. Distally of passageway 362, the flatsurfaces of actuation tips 229 form open-sided staple chamber 345, whichcontains anvil 350. In an alternative embodiment, only one of theexpansion tips includes the side rails and the side rails abut againstthe flat surface of the other expansion tip. In such an embodiment, theside rails may be thicker than in an embodiment with side rails on eachexpansion tip in order to create the appropriately-sized passageway 362and staple chamber 345. Although this description of the expansion tipshas referred to expansion tips 329 a and 329 b, it would be understoodthat it applies equally to expansion tips 229.

Fourth Staple Release Mechanism

Similar to the description above with respect to staple 230 and FIGS.15-19, staple 330 must clear anvils 350 a/b in order to be released fromstapler 328. Such, release can be accomplished by the mechanisms andmethods described above with respect to FIGS. 31-45. In particular,anvils 350 a and 350 b may include proximally-facing ramps 352 a and 352b, as shown in FIGS. 20-22 and 39-44. After expansion ramps 334 a and334 b clear anvils 350 a/b, and the elastic or shape memory property ofstaple 330 causes staple tips 339 a and 339 b to close toward eachother, as shown in FIG. 22. To release staple 330 from stapler 328,driver 340 may be held in place longitudinally as proximally-directedforce is applied to hollow shaft 327. Thus, driver 340 holds staple 330against, the proximally-facing surfaces of anvils 350 a and 350 b, andholds staple tips 339 a and 339 b in the vessel wall about thearteriotomy. In this way, actions taken to release staple 330 fromstapler 328 do not pull proximally on staple 330 once it is engaged withthe tissue of the vessel wall. However, because the proximally-facingsurfaces of anvils 350 a and 350 b are ramps 352 a and 352 b,respectively, proximal movement of hollow shaft 327 forces ramps 352 aand 352 b to separate around the proximal bend of staple 330, therebycausing actuation tips 329 a and 329 b to spread apart, creating a gap372 between anvils 350 a and 350 b, as shown in FIG. 41. As hollow shaft327 continues to be moved proximally, anvils 350 a/b clear staple 330,which is thereby released from stapler 328. Thus, stapler 328 releasesdeployed staple 330 by forcing actuation tips 329 a and 329 b to spreadapart by engaging ramps 352 a and 352 b with staple 330 itself. Hollowshaft 327 and driver 340 can then be removed from the body.

Third Stapler Embodiment

Another embodiment of a stapler 428 is shown in FIGS. 42-45. As shown,stapler 428 includes a staple 430 that is similar or identical to staple330 described above and is made of nitinol or other suitable elastic orpseudoelastic shape memory alloy (SMA). However, staple 430 of thepresent embodiment can also be similar in shape and material propertiesto staple 230 shown and described with respect to FIGS. 15-19.

Stapler 428 further includes actuation tips 429 a/b. Only actuation tip429 a is shown in FIGS. 42-44 for ease of viewing, however, it would heunderstood by one of ordinary skill in the art that actuation tip 429 bis a mirror image of actuation tip 429 a, as shown in FIG. 43. Actuationtip 429 a includes anvil 450 a similar to anvil 350 a described withrespect to FIGS. 20-24. Actuation tip 429 a further includes first andsecond laterally opposed side ramps 454 a and 456 a disposed abuttingthe distal end of anvil 450 a. Side ramps 454 a and 456 a may be formedintegrally with anvil 450 a. Stapler 428 further includes an elongatedriver 440 and a staple 430, similar or identical to driver 340 andstaple 330 described above with respect to FIGS 20-24. Staple 430includes staple expansion ramps 434 a and 434 b.

In use, when stapler 428 is located in the proper position relative tovessel 102, driver 440 is advanced within hollow shaft 424 such that thedriver distal end pushes staple 430 distally in the staple chamberbetween expansion tips 429 a/b such that staple expansion ramps 434 aand 434 b ride along, and are forced apart by anvil 450 a/b, as shown inFIG. 42. The separation of expansion ramps 434 a and 434 b causes thelegs of staple 430 to separate and extend laterally from the open sidesof the staple chamber in the distal end of hollow shaft 424. In asimultaneous action, staple, tips 439 a and 439 b are spread apart andstaple 430 is advanced distally such that staple tips 439 a and 439 bpierce the vessel wail to engage vessel tissue on either side ofarteriotomy 132. Note that the forces that act to spread apart stapletips 439 a and 439 b do not act orthogonally to simultaneously spreadapart actuation tips 429 a and 429 b. As driver 440 continues to pushstaple 430 distally, expansion ramps 434 a and 434 b clear anvil 450a/b, and staple tips 439 a and 439 b close toward each other to gatheror pucker the engaged tissue, thus closing arteriotomy 132.

Staple 430 may be released from stapler 428 simultaneously with orsubsequently to deployment of staple 430 to close arteriotomy 132.Driver 440 may be held in place longitudinally as proximally-directedforce is applied to hollow shaft 424 to release staple 430. Thus, driver440 holds staple 430 in the closed configuration about the arteriotomy.That is, actions taken to release staple 430 from stapler 428 do notpull proximally on staple 430 once it is engaged with the tissue of thevessel wall. As can be seen in FIGS. 42 and 44, when staple tips 439 aand 439 b close toward each other, the tips of expansion ramps 434 a and434 b will also close toward each other and engage first side ramp 454 aand second side ramp 456 a, respectively. The closing force of staple430 will wedge expansion ramp 434 a between first side ramps 454 a/b,and will simultaneously wedge expansion ramp 434 b between second sideramps 456 a/b. Such wedging action will force actuation tips 429 a/bapart.

With actuation tips 429 a and 429 b spread apart from each other, a gapis formed between anvil 450 a of actuation tip 429 a and anvil 450 b ofactuation tip 429 b. Hollow-shaft 424 may then continue to be movedproximally over driver 440, such that the gap formed between anvils 450a/b clears staple 430, which is thereby released from stapler 428. Thus,stapler 428 releases deployed staple 430 by forcing actuation tips 429 aand 429 b to spread apart by the closing force of staple 430 actingagainst side ramps 454 a/b and 456 a/b. Hollow shaft 424 and driver 440can then be removed from the body. The closing force of staple 430 maybe an inherent elastic, resilient or shape memory property similar tothat of staple 330. Alternatively, the closing force of staple 430 maybe the result of moving driver 440 within hollow shaft 424 toplastically deform staple 430 into a closed configuration, as describedabove with respect to staple 230 shown in FIGS. 15-19. Note that, asdescribed above, stapler 428 may include a single anvil extending fromone actuation tip toward the other actuation tip instead of a pair ofanvils 450 a and 450 b.

Center Tube with Staple Protection

In the embodiments described above, closure system 122 may be advancedalong stabilization wire guides 114 through tissue track 101 without asheath placed in tissue track 101. Further, as described above, any oneof staplers 128, 228, 328, or 428 may be slidably disposed within centertube 124 and may be advanced through tissue track 101 together withcenter tube 124. Tips of staples 130, 230, 330, and 430 extend distallyfrom the respective staplers, even prior to initialing deployment of thestaples. Thus, while closure system 122 is being advanced to thearteriotomy site, it may be desirable to protect staple 130, 230, 330,or 430 against possible damage from tissue track 101, or conversely, itmay be desirable to protect tissue track 101 against possible injuryfrom staple 130, 230, 330, or 430.

FIGS. 25 and 26 show an embodiment of a center tube 424 having at itsdistal end at least two opposing longitudinal slots aligned with theside openings in the staple chamber of staplers 128, 228, 328, or 428,as described above. Center tube 424 further includes a pair of opposingcorners 427 defined where each slot meets the distal opening of centertube 424. During staple deployment wherein center tube 424 is advancedclose to vessel 102, the legs of staples 130, 230, 330, or 430 canexpand laterally from staplers 128, 228, 328, or 428 into the distalslots in center tube 424. In an alternative embodiment shown in FIGS. 11and 12, the center tube lacks distal slots such that staplers 128, 228,328, or 428 must be advanced until staples 130, 230, 330, or 430 held inthe staple chamber are outside of the center tube before stapledeployment is initiated. In this embodiment, the center tube must bespaced away from vessel 102 a sufficient distance such that, duringdeployment, the stapler can be advanced to the point where a staple canexpand laterally without binding on the center tube.

To prevent contact between staple tips and tissue track 101, asdiscussed above, center tube 424 is provided with an inwardly tapered orpinched distal portion 425, which at least partially covers or guardsthe staple tips. In the embodiment shown, pinched distal portion 425brings together corners 427 in center tube 424. As in embodimentsdescribed above, center tube 424 is advanced along stabilization wireguides 414 via side lubes 426. Pinched distal portion 425 protectsstaple 430 from damage while being advanced through tissue track 101, orprotects tissue track 101 from injury by staple 430 passing therethrough. When center tube 424 is advanced to a position outside of thevessel, expansion tips 429 a and 429 b are advanced distally, openingpinched distal portion 425 and spreading the distal ends of the distalslots in center tube 424, as shown in FIG. 26. Staple 430 is then openedand closed around the arteriotomy as described in the embodiments above.

Alternatively, staple 430 may be deployed without advancing the distalend of the stapler beyond the distal end of center tube 424. In thiscase, the opposing legs of staple 430 are permitted to expandtransversely from the open sides of the staple chamber and to spreadthrough the center tube slots, which are aligned with the open sides ofthe staple chamber.

In another embodiment, the staple may be protected using a frangible cap574, as shown in FIGS. 27 and 28. Frangible cap 574 is fixed to andcovers a distal portion of a center tube 524, and includes a planarportion 576 extending across a distal opening of center tube 524.Frangible cap 574 may be a biocompatible polymeric membrane or abiocompatible metallic foil, and may include perforations, grooves orother disruptions that define tear lines within the cap. Frangible cap574 may comprise one or more polymers such as polyurethane, polyester orpolystyrene. More resilient polymers for making frangible cap 574 maycomprise natural or synthetic rubber such as butadiene/acrylonitrilecopolymers, copolyesters, ethylene vinylacetate (EVA) polymers,ethylene/acrylic copolymers, ethylene/propylene copolymers,fluorosilicone, latex, polyalkylacrylate polymers, polybutadiene,polybutylene, polyethylene, polyisobutylene, polyisoprene, polyurethane,silicone, styrenebutadiene copolymers,styrene-ethylene/butylene-styrene, thermoset elastomer, thermoplasticelastomer and combinations of the above. Polymeric frangible cap 574 maybe formed by various methods including casting, compression molding,liquid injection molding, reaction injection molding (RIM), resintransfer molding (RTM), and thermoplastic injection molding. Polymericfrangible cap 574 may be molded of soft foam, solid elastic material, ora combination thereof.

Frangible cap 574 separates staple 530 from tissue track while centertube 524 is advanced through a tissue track along stabilization wireguides 514 via side tubes 526. Once center tube 524 has been advanced toa position outside of the vessel 102 a stapler 528 carrying staple 530is advanced distally through center tube 524 such that the staple tipsand/or the distal end of stapler 528 penetrate or fracture frangible cap574, as shown in FIGS. 28 and 44. In the embodiment shown in FIG. 28, asstapler 528 exits the distal end of center tube 524, at least planarportion 576 of frangible cap 574 tears into a configuration having oneor more deflectable sections 577 such as flaps that swing, stretch, orotherwise move aside, while frangible cap 574 remains integral and fixedto center tube 524. Staple 530 is then opened, engaged and closed aroundthe arteriotomy as described in the embodiments above.

In an alternative embodiment of the disclosure shown in FIGS. 29 and 30,as stapler 528 exits the distal end of center tube 524, frangible cap574′ tears into a configuration wherein a generally planar pledget 578separates from the remainder of frangible cap 574′, which stays fixed tocenter tube 524. Pledget 578 is carried on the distal end of stapler 528and is implanted with staple 530 to aid in closing arteriotomy 132, asdescribed in U.S. Published Patent Application Number 2004/0093024 A1 toLousararian et al., the entire disclosure of which is incorporatedherein by reference. Pledget 578 may comprise a part of, orsubstantially all of planar portion 576 of frangible cap 574′. Pledget578 may have circumferentially spaced notches for frictional engagementwith, and centering between the legs of staple 530, as described in theabove-referenced Lousararian publication.

As shown in FIG. 30, pledget 578 may promote hemostasis by stemming theflow of blood from arteriotomy 132 that is being closed by staple 530.Additionally, pledget 578 may be either bio-resorbable ornon-resorbable, and may include physiologically active agents such asCefazolin, chlorhexidine, fusidic acid, Novobiocin, polymyxin B,rifampicin, silver or a silver compound, or tetracycline for inhibitionof infection. Alternative physiologically active agents may includecollagen or derivatives thereof, heparin, or phosphorylcholine forpromotion of extraluminal clotting. Such physiologically active agentsmay be coated onto, absorbed within, or otherwise incorporated into thematerial of pledget 578.

While various embodiments of the present disclosure have been describedabove, it should be understood that they have been presented by way ofillustration and example only, and not limitation. It will be apparentto persons skilled in the relevant art that various changes in form anddetail can be made therein without departing from the spirit and scopeof the disclosure. Thus, the breadth and scope of the present disclosureshould not be limited by any of the above-described exemplaryembodiments, but should be defined only in accordance with the appendedclaims and their equivalents. It will also be understood that eachfeature of each embodiment discussed herein, and of each reference citedherein, can be used in combination with the features of any otherembodiment. All patents and publications discussed herein areincorporated by reference herein in their entirety.

1. A closure device for an arteriotomy comprising; an elongate tubehaving a distal opening and at least two opposing longitudinal slotsextending proximally there from and a pair of opposing corners definedwhere each slot meets the distal opening of the tube; and a staple beingslidably disposed within the tube and having at least two opposing legsaligned with the at least two slots, each staple, leg having a tip;wherein each slot is pinched together adjacent the distal opening suchthat the opposing corners of each slot converge to cover at least thetip of the respective staple leg.
 2. The closure device of claim 1wherein, the opposing corners of each slot are separable to permit therespective staple leg to pass there between.
 3. The closure device ofclaim 1 wherein the elongate tube includes at least two side tubes forriding along a pair of stabilization wire guides, the side tribes beingcoupled parallel to, and disposed on opposing sides of a distal portionthe elongate tube.
 4. The closure device of claim 1 further comprisingan elongate stapler slidably disposed within the elongate tube, thestapler comprising; an elongate hollow shaft and an elongate driverslidably disposed therein; a pair of opposing actuation tips disposed ata distal end of the shaft and defining an open-sided staple chamberthere between, the open sides of the chamber being aligned with the atleast two slots in the elongate tube; and an anvil fixedly disposedwithin the staple chamber; wherein at least a proximal portion of thestaple is held within the staple chamber.
 5. The closure device of claim1 further comprising an elongate stapler slidably disposed within theelongate tube and holding at least a proximal portion of the staple. 6.The closure device of claim 5 wherein the stapler comprises: an elongatehollow shaft and an elongate driver slidably disposed therein; a pair ofopposing actuation tips disposed at a distal end of the shaft anddefining a staple chamber there between; and an anvil disposed withinthe staple chamber and affixed to one of the actuation tips; wherein atleast a proximal portion of the staple is held within the staplechamber.